SCOPE 2017 Summit for Clinical Operations Executives Summary

The 8th Annual SCOPE Summit took place from January 24th to 26th in Miami, Florida, and included in-depth discussions on issues related to each aspect of clinical operations and clinical trial management and planning, plus 6 pre-conference workshops and 2 symposia.

Featuring more than 1,200 participants and diverse topic streams of site activation, recruitment, budgeting and management, outsourcing, monitoring, data, real-world evidence, and precision medicine, the conference began with a beautiful sunrise over Miami (full credit to Longboat'sAidan Gannon for this amazing picture!).

Over 3 days, SCOPE 2017 packed in discussions on and best-practices for study management across a vast range of timely topics including (to name a few): protocol development and evidence-based feasibility; patient-centered trials; implications of the ICH E6 Addendum; implementing risk-based monitoring; strategies for financial forecasting and determining outsourcing needs; integrating patient insights into clinical trial planning; and wearables and digital clinical technology. Interactive breakout sessions were led by industry thought-leaders, many of whom presented real-life case studies and shared lessons learned from their own direct company experience. Meanwhile on the exhibition floor, attendees had the opportunity to see new and innovative companies and technologies at the cutting edge of the clinical trial space.

Highlights of day 1 sessions attended by the Longboat crew included the interactive panel titled ‘Rethinking the Design and Planning Approaches for Clinical Trials’ led by Pfizer’s Craig Lipset, Head of Clinical Innovation, R&D, which opened discussions about how to approach study design and planning in novel ways. Panelists including Katherine Vandebelt (Eli Lilly), Christine Pierre (Society for Clinical Research Sites), Bardia Akbari (Genentech) and Murray Abramson (Biogen) spoke about the potential for the use of ambient technology to help patients and rapid technological advancements in our day-to-day lives that could be adapted to transform clinical trials, all the while balancing the idea that regardless of the technology, the human elements of judgement, wisdom, and ethical awareness are invaluable. Finishing out day 1, delegates split into 19 tables for interactive breakout discussions, which enabled active idea sharing and peer discussion.

Day 2 brought a theme of moving towards the trials of the future and getting from Powerpoint to action stage for new technologies and strategies, with a focus on the best ways to innovate and whether innovation teams should exist outside of our mainstream operations or be fully integrated. In the risk-based monitoring (RBM) stream, an interactive panel on how to bring together key stakeholders in RBM models included shared experiences from Gilead, UCB Biosciences, Bioclinica, Covance, and PPD. Exostar hosted a drinks reception where discussions spilled over into the evening.

On the final day, the patient engagement stream included inspiring presentations by Angela Radcliffe of FCBVIO about the ‘Inspiring Hope Ideathon’ and how to address the clinical trial awareness gap. Eli Lilly’s Kelly McKee told the moving story of how the Hero’s Journey (crowdsourced art initiative) is celebrating clinical trial participants and raising awareness of clinical research. Holly Beisner of Eli Lilly gave us useful information on managing e Consent and the Transcelerate e Consent initiative. Barbara Zupancic of Worldwide Clinical Trials who explained how her team are managing patient recruitment for lasting engagement and success in Alzheimer’s studies.

A special shared session on the future of truly patient-centric trials and how to move towards this now rounded out a very informative and interactive conference. Fantastic to see how initiatives being discussed last year have made strides forward during 2016/2017 and how pharma companies are coming up with innovative ways to implement new operational strategies and keep integrating emerging technologies into their trials. Looking forward to #SCOPE 2018 in Orlando!